Pembrolizumab in Treating Patients With Hormone Receptor Positive Localized Inflammatory Breast Cancer Who Are Receiving Hormone Therapy and Did Not Achieve a Pathological Complete Response to Chemotherapy
This phase II trial studies how well pembrolizumab works in treating patients with hormone
receptor positive inflammatory breast cancer that has not spread to other parts of the body,
who are receiving hormone therapy and did not achieve a pathological complete response to
chemotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the
body's immune system attack the cancer, and may interfere with the ability of tumor cells to
grow and spread.
I. To determine the disease free survival (DFS) at 2 years of patients with maintenance
therapy using pembrolizumab in combination with standard adjuvant hormonal therapy.
II. To determine the safety and toxicity profile of primary inflammatory breast cancer (IBC)
patients who received combination of pembrolizumab and hormone receptor blockade.
I. To investigate the association between immune related biomarkers in the peripheral blood
and tumor tissue, such as PD-L1 expression, with safety and efficacy for IBC patients treated
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Cycles repeat
every 21 days for up to 24 months in the absence of disease progression or unacceptable
After completion of study treatment, patients are followed up at 1 and 24 months.
Inflammatory Breast Cancer,
Estrogen Receptor Positive,
Progesterone Receptor Positive,
Anatomic Stage IIIB Breast Cancer AJCC v8,
Anatomic Stage IIIC Breast Cancer AJCC v8,
Prognostic Stage IIIB Breast Cancer AJCC v8,
Prognostic Stage IIIC Breast Cancer AJCC v8,
inflammatory breast cancers
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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